NEW DEFECTIVE DRUG RECALL AFFECTS SUDAFED, BENADRYL & TYLENOL NONPRESCRIPTION DRUGS. RECALL LINKED TO TROUBLED PENNSYLVANIA FACILITY MANUFACTURING PROBLEMS.
What’s the problem?
J&J / McNeil is currently recalling nearly 47 million packages of Sudafed and other nonprescription drugs due to insufficient cleaning procedures conducted at a Pennsylvania facility that has already been subject to a series of massive recalls. The products being recalled were manufactured at McNeil’s Fort Washington, Pa. facility before it was closed in April following an FDA investigation. Inspectors reportedly found manufacturing problems at the plant, including equipment covered with thick layers of dust and others held together with duct tape.
Specific Sudafed products affected by this recall include (Product Name/Lot Number/UPC):
SUDAFED PE® DAY & NIGHT COLD COATED CAPLETS 20 count
AFC075, ALC109, APC130, BAC015
SUDAFED PE® COLD & COUGH COATED CAPLETS 10 count
SUDAFED PE® COLD & COUGH COATED CAPLETS 20 count
AJM350, AJM351, AJM363, AMM302, APM347, ASM351
SUDAFED PE® NON-DRYING SINUS COATED CAPLETS 24 count
ALM329, ALM462, BAM200
SUDAFED PE® SEVERE COLD COATED CAPLETS 12 count
AEM075, AHM430, ALM392, AMM329, AMM425, ASM356, BBM200
SUDAFED PE® SEVERE COLD COATED CAPLETS 24 count
AFM061, AHM429, AHM442, AMM358, AMM423, APM426, ASM453, BCM136
SUDAFED PE® NIGHTTIME COLD COATED CAPLETS 20 count
ALM428, ASM355, BAM262
SUDAFED PE® SINUS HEADACHE COATED CAPLETS 72 count CLUB CODE
ABM043, ACM041, ACM055 ACM061, AEM089, AHM371 AHM377, AJM361, APM423 BAM267, BCM138, BCM178
SUDAFED PE® SINUS HEADACHE COATED CAPLETS 48 count
AEM088, ALM391, BCM137, APM354, BAM266
SUDAFED PE® Triple Action COATED CAPLETS 24 count
AEM106, AFM028, AHM437, AHM445, AJM303, AJM422, ALM319, ASM306, ASM353, BAM269, ALM320, ALM384